Rhinomanometer NR6
NR6 User
’s
Manual V 16 14/02/2020 P5 of 34
CAUTIONS
Patient connection components may cause an irritation reaction in some patients. Use of
such components should be discontinued in patients who exhibit such a reaction.
Certain components are identified as single-use items. Single-use items should not be
reused as they could carry infections between subjects
Federal (USA) law restricts this device to sale by or on the order of a physician.
The use of an NR6 Rhinomanometer near to sources of electromagnetic radiation, such as
mobile phones, radio transmitters, x-ray equipment etc, may prevent it from functioning
correctly. Appendix 1 provides guidance on the Electromagnetic environment in which to
operate the instrument.
The NR6 Rhinomanometer is a medical instrument which has a Medical Device Directive
Classification of Class I with a measuring function.
Applied parts offer protection to the subject against electrical shock and in the event of a
single fault condition arising, leakage current will be limited to less than 0.5 mA.
Any incident, which results in actual or potential injury or death to a subject while using an
NR6, should be immediately communicated to GM Instruments at the address on page 8.
Non-medical equipment such as computers and printers should be kept out of reach of
subjects being tested as such equipment does not comply with medical safety standards,
please see the earlier definitions shown in Figure 1. The combination of the
Rhinomanometer and computer and/or printer make up a medical system, refer to the
current version of EN 60601-1 to ensure compliance.
If the PC is allowed to go into sleep mode, the USB interface is powered down. When brought
out of sleep mode, the PC does not re-initialise the USB interface, and therefore it is effectively
not present. A solution is to remove the USB connection at the PC or instrument side then re-
connect. That may be sufficient, but if not, save any results, then close down the instrument
software and restart it.
Servicing can only be carried out by GMI approved and
authorised personnel. No modifications are allowed
.
